Quality Associate - Quality Operations

Cencora • Columbus, OH

5d

About The Position

The Quality Associate supports Cencora’s U.S. distribution services through its AmerisourceBergen business. The role provides direction and guidance to daily quality assurance and production activities, supporting compliance, product quality, and production needs. The schedule is Monday through Friday, 3:00 p.m. to 11:30 p.m., at a pay rate of $21 per hour.

The position audits production batch records and conducts final audits before submission for product release. It also carries out serialization activities, resolves certain product and packaging component discrepancies, performs quality in-process checks and specified testing, and supports cleaning validation. The Quality Associate helps maintain work instructions and SOPs, escalates non-conformances, and participates in quality investigations and continuous improvement. The position works with supporting departments and participates on the site internal audit team representing QA Production.

Requirements

• High school diploma or GED.
• Ability to read and understand English for documents, product labels, and instructions.
• Good writing skills for accurately completing production compliance documentation.
• In-depth knowledge of the function and basic problem-solving capabilities for troubleshooting production issues.
• Basic mathematical skills.
• Strong interpersonal skills and ability to develop and maintain cooperative working relationships.
• Strong organizational skills and attention to detail.
• Good judgment in carrying out detailed instructions.
• Ability to work independently and handle multiple tasks simultaneously.
• Good verbal and written communication skills.
• Computer literacy, including ERP systems, Microsoft Office (Outlook, Word, and Excel), and computer-based training.
• Ability to lift up to 50 pounds with assistance.
• Close, distance, and peripheral vision and ability to adjust focus.
• Ability to deal with stressful situations as they arise.

Responsibilities

• Provide direction and guidance to daily QA and production activities.
• Audit production batch records throughout the packaging process for accuracy and compliance.
• Conduct a final audit before submitting records to Product Release.
• Perform serialization activities, including sending print, releasing, suspending, and cloning work orders to support production needs.
• Verify and correct non-controlled product and packaging component discrepancies in applicable systems.
• Ensure applicable deviations and supporting documentation are included in batch records.
• Perform quality in-process checks as needed.
• Perform Specific Gravity testing and TOC analysis.
• Perform Cleaning Validation swabbing when requested by the Stability department.
• Create, review, and update work instructions and SOPs applicable to daily activities.
• Escalate production non-conformance issues to management and lead root cause analysis of quality incidents.
• Participate in investigation discussions and draft Unplanned Deviations for management review.
• Complete required technical, compliance, and other quality-team training.
• Work with Sampling, Label and Documentation, Production, and Warehouse teams to resolve issues and improve processes.
• Participate in continuous improvement activities to increase efficiency and team member engagement in the production area.
• Participate on the site internal audit team representing QA Production.
• Adhere to cGMP and safety regulations and understand SOPs.
• Perform other duties as assigned.

Benefits

• Medical, dental, and vision care.
• Wellness resources addressing physical, emotional, financial, and social well-being.
• Support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.
• Training programs, professional development resources, and mentorship opportunities.
• Employee resource groups and volunteer activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED